Does Early vs. Late Surgery in Glue Ear Improve Language Development?
ABSTRACT & COMMENTARY
Synopsis: There is some, but marginal, benefit in speech and language development from ventilation tube insertion for children with persistent (> 3 months) otitis media with effusion and hearing impairment. However, the degree of improvement did not differ from children who had surgery within six weeks or those who had surgery after nine months of "watchful waiting."
Source: Maw R, et al. Early surgery compared to watchful waiting for glue ear on language development in preschool children: A randomized trial. Lancet 1999;353:960-963.
Otitis media with effusion (OME) is the most common cause of hearing loss in children and is generally treated by elective surgery involving the insertion of ventilation tubes. Maw and associates at the Bristol Children’s Hospital in the United Kingdom performed a randomized, controlled study of 186 children born between April 1991 and January 1992 who were diagnosed as having bilateral OME and hearing impairment of 25-70 dB of at least three months’ duration. Children were randomly assigned to have surgery within six weeks (n = 92) or to a "watchful waiting" group (94) who were followed for nine months, after which bilateral tube replacement was done if still indicated. Hearing loss, expressive language, and verbal comprehension were measured at baseline, nine months, and 18 months. At nine months, standardized scores for verbal comprehension and expressive language development were 3.24 months behind in the watchful waiting group compared to the early surgery group. These differences, after adjustment for baseline differences, were statistically marginal (P = 0.04 and P = 0.028, respectively.) These differences persisted at 18 months. By 18 months, 85% of the watchful waiting group received surgery. Maw et al conclude that there is a small benefit for ventilation tube placement, but the time of surgery does not appear to be critical.
Comment by David E. Karas, MD
Maw et al randomly divided 186 children with persistent, bilateral OME and hearing loss for more than three months into two groups. One group that met their criteria for tympanostomy tube placement (which, incidentally, was never clearly spelled out in the paper) had tympanostomy tubes placed within six weeks. The other group was designated the "watchful waiting" group and was followed for up to nine months after which they had tube placement if still necessary.
It is a good idea to study whether the timing of surgery is important in long-term outcome, but there are some real problems of experimental design and interpretation in this study that concern me. This paper indicates that ultimately 85% of the "watchful waiting" group still got tympanostomy tubes and still did more poorly than the surgical group. Several questions arise from this study. When exactly did the watchful waiting group get its tympanostomy tubes? Did they get tubes one month into the study, 17 months into the study, or at the completion of the nine-month study period? Because 85% of the watchful waiting group ultimately got tympanostomy tubes, they may not serve as real controls for the early surgical group.
In reviewing the data for the early treatment compared to the watchful waiting group, it is not clear to me why 63% of the early treatment group failed a seven-month hearing screening test. This suggests to me that these children either have persistent underlying hearing loss or that their tympanostomy tubes are not working, and the children have continuing effusions that are causing conductive hearing loss. This does not differ significantly from 66% in the watchful waiting group. This finding would be significant in terms of whether the tubes were functioning, resulting in a measurable difference in speech and language skills. Maw et al conclude that there is some benefit in speech and language with early placement of tympanostomy tubes for persistent middle ear effusion because children in the watchful waiting group were 3.24 months behind the early surgery group. Once this was corrected for baseline findings, the differences were still statistically significant, although somewhat smaller than the 3.24 months would indicate. Maw et al conclude that there is a small benefit from tube placement, but timing of surgery is not a significant factor. Based on some of their data, I’m not sure of this conclusion, based on the fact that 85% of the children still got tympanostomy tubes despite observing them for nine months. This would, in fact, lead me to come to an opposite conclusion. Since most of these patients ultimately require tympanostomy tube placement and since there was clearly a small but definite benefit from early tube placement, I would argue for early surgical intervention in children with persistent OME associated with hearing loss. (Dr. Karas is Head of Pediatric Otolaryngology at Yale University School of Medicine, New Haven, CT.)
True statements concerning persistent (> 3 months) bilateral otitis media with effusion include all of the following except:
a. It may result in conductive hearing loss.
b. Hearing loss may continue after tympanostomy tube placement because of tube dysfunction.
c. It ultimately regresses without surgery.
d. It is a common cause of hearing loss.
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